Preparation / Review of Technical Files & Design Dossiers

As part of our involvement with the UK Notified Bodies, RSQA has probably reviewed and reported upon more medical device Design Dossiers than any other UK consulting company.

This makes us uniquely placed to offer constructive advice on the compilation of these documents which, as manufacturers may be well aware is an area where no specific authoritative guidance exists.

As an extension of our activities in this area, we also offer manufacturers regulatory compliance offices the facility of compilation of Design Dossiers, using the manufacturers data.

This service is absolutely confidential to the manufacturer concerned,
and we take steps to ensure that through our relationships with UK Notified
Bodies we could not be involved in the review of Dossiers which we had
ourselves compiled.

For medical devices of lesser Classification, manufactures are obliged to compile Technical Files to fully characterise the device and document how compliance with the Medical Device Directives Essential Requirements is demonstrated.

Within this area also RSQA has the most extensive expertise, and can advise in detail upon recommended content, or compile information on manufacturers behalf so as to fulfil all regulatory requirements and ensure clear passage through the audit process to CE certification.

There are similarly a great many manufacturers, the Classification of whose
devices is such that their Technical Files may never be reviewed by a
Notified Body, e.g. Class I non-sterile. All such manufacturers and their
devices must be registered with the UK Medical Devices Competent Authority,
the Medicines and Healthcare products Regulatory Agency (MRHA).

The MRHA, in fulfilling its role in ensuring the safety and efficacy of
all medical devices manufactured / marketed within the UK, and in particular
those which manufactures may self-certify, periodically samples manufacturers
Technical Files as part of an ongoing Regulatory Compliance exercise.
Any Class I device manufacturer may be required to submit files to the
MRHA for examination in pursuit of possible breaches of the Medical Devices
Regulations.

We offer such manufacturers the benefit of our experience in this area
- one of our staff was formerly one of the MDAs (now MHRA) first
Compliance Inspectors - with the aim of providing assurance and peace
of mind that should files be called for examination all will be in good
order.